TOPIC: The Slow Grinding Mills of the FDA

Back in 2012-3 when I did spend quite some time at LinkedIn discussing the development of cell technology with peers, a Company by the name of BioInformant was founded from which I still receive regular emails, since of course they are trying to sell information- also to me (in vain though).
The mail that I received a few days ago- kind of shocked me. They point at the extremely low level of approved SC products, but at the same time point at the availability- clearly illegal- of therapies at the 425+ clinics selling unapproved treatments and yes, are now offering a database with names of those establishments - totally hypocritical in my view-

To date, the U.S. FDA has approved 16 cell and gene therapy products, half (8) of which are umbilical cord blood derivatives.

As stated by the FDA, "The only stem cell-based products that are FDA-approved for use in the U.S. consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood."

In addition to these FDA approved therapies, a diverse range of stem cell therapies are being offered directly to patients.

Over the past five years, the number of physicians offering stem cell treatments has expanded exponentially. These services include, but are not limited to, treatments involving stem cells derived from bone marrow, adipose tissue, or peripheral blood, as well as cells derived from umbilical cord blood and tissue, placental blood and tissue, amniotic fluid and tissue, and more.

With the rapid expansion of this market area, numerous clients requested that we tackle the daunting task of compiling these stem cell treatment providers into a single searchable, sortable database.

As the world's first and only market research firm to specialize in the stem cell industry, it is not BioInformant's role to assess the regulatory compliance of these medical centers. This responsibility falls squarely under the purview of the U.S. FDA, European EMA, Japanese PMDA, and other regulatory bodies worldwide.

Rather, our role is to provide a tool for instantly identifying physicians who offer stem cell treatments/therapies within the scope of their medical practice.

Featuring 425+ clinics, the "Database of Stem Cell Treatment Providers" was developed for our own purposes, but we have had more and more clients requesting access to it.

For this reason, we are releasing it to the public – for a limited-time only.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology.

Anyway- out of curiosity I paid a visit to the site of Paul Knoepfler - one of the view who is recognized of vehemently is reminding the FDA of their duty to enforce their own established rules to all participants in the medical industry, in which respect they made a start in starting legal proceedings against the Cell Surgical Network and US Stemcell Inc

An assessment by professor Patricia Zettler on the time it will take to bring these legal actions to resolution - one excerpt from the interview Knoepfler did with her - you find below-

PK: How long might these court cases take?

PZ: It’s tough to predict, but it will certainly take a while if the cases are litigated rather than settled. For example, in the Regenerative Sciences case, FDA filed its complaint asking for a permanent injunction in August 2010, and the trial judge granted that request in July 2012. Regenerative Sciences then appealed, and the D.C. Circuit affirmed the district court’s judgment in February 2014.

Having spoken to some of the defendants, you probably have a better sense than I do as to whether they intend to litigate this—but I would guess perhaps yes, given some of their statements arguing that they are not subject to FDA regulation and the fact that the activities that FDA has asserted are illegal appear necessary for their current business models.

So - still 3 years to come????

The Slow Grinding Mills of the FDA

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology.